Proportion of Participants Who Experienced a ≥ 50% Reduction in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH/National Eye Institute (NEI) Visual Analogue Scale in the Study Eye From Baseline to Month 3.

Number of Systemic and Ocular Toxicities and Adverse Events

Number of Participants Withdrawn From the Study Treatment Due to Vision Loss, Adverse Events or Treatment Failure

(and 20 more...)

18

All

18 Years and older (Adult, Older Adult)

NCT01972438

13020613-EI-0206

GVHD ASED

November 2013

May 2015

January 2016

October 30, 2013

December 8, 2016

September 13, 2016

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland, United States

Proportion of study eyes improving by a 15-letter score or more in best-corrected visual acuity (BCVA) from baseline measured using electronic visual acuity (EVA)

The proportion of study eyes improving by a 10-letter score or more in BCVA from baseline using EVA.

The proportion of study eyes improving from baseline in five or more locations of the Humphrey visual field (HVF) 24-2 full-threshold with the size V stimulus on the glaucoma change probability map (GCPM) at the 5% level by group.

234

All

50 Years and older (Adult, Older Adult)

NCT03547206

RGN-ON-002

July 10, 2018

November 2019

May 2020

June 6, 2018

May 2, 2019

Byers Eye Institute at Stanford UniversityPalo Alto, California, United States

Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.

Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys.